Gentle hemorrhoid treatment offering a substantially painless healing

ABSTRACT

The teachings provided herein are directed to a methods and devices for treating a hemorrhoid in a subject in a manner that produces substantially less post-procedural pain in the subject, the method minimizing or avoiding a removing or a necrosis of a rectal tissue fold.

BACKGROUND

1. Field of the Invention

The teachings provided herein are directed to methods and devices forgently treating a hemorrhoid in a subject in manner that producessubstantially less post-procedural pain in the subject, the methodavoiding a removing or a necrosis of a rectal tissue fold.

2. Description of the Related Art

Hemorrhoids present a worldwide problem that needs a gentle, yeteffective, treatment with substantially less post-procedural pain.Moreover, those of skill in the art would appreciate having less complexand less expensive equipment for administering the treatment. Bleedingfrom hemorrhoids is the most common cause of rectal bleeding, which maycause anemia or be responsible for the person's substantially decreasedquality of life. Prolapsed hemorrhoids, in particular, can create aquite serious discomfort to a patient, and the situation can get worseas the patient avoids the painful state-of-the-art treatments. As thepatient avoids treatment, for example, a hemorrhoidal tissue can becomeredundant and/or suspensory ligaments can weaken. The hemorrhoid and/orlower rectal tissue folds, mucosal and submucosal, can then prolapseoutside the rectum and cause bleeding and pain to the patient. Thetissue, in effect, starts to become prone for prolapse; mobile from itsoriginal, healthy position in the patient; and move in and out of theanus creating inflammation, discomfort, pain, bleeding, infection, andthe like. When further left untreated, the prolapse becomes morefrequent and more prominent. Finally, hemorrhoids would becomeconstantly prolapsed or would prolapse with a minor strain only, forexample, during light coughing, sneezing, or even after walking orstanding for a few minutes.

Current, state-of-the-art treatments are typically not gentle but,rather, are cumbersome for the physician and painful to the patient. Themost popular methods generally call for use by a colorectal surgeon, inaddition to an assistant. And, such methods often require the use of theexpensive and demanding-in-use, multi-component instruments. Anothergroup of the instruments for gastroenterologists requires costly andcomplex endoscope equipment, such as a power source, an optical fiberarrangement and camera system, and a computer processor. Thesetreatments are associated with significant tissue trauma and, forexample, can be designed to include tissue banding, cutting and/orstapling devices that lead to the removal, and/or intentional necrosisof rectal tissue, resulting in a substantial post-procedural pain.

Accordingly, one of skill will appreciate having a method of treating ahemorrhoid, or other such anorectal lesion, that (i) is simple, easy tolearn, less cumbersome, and more cost-effective than current,state-of-art methods, in that it does not require the use of the morecomplex, cumbersome, and expensive systems; (ii) can be used without anassistant; (iii) can be readily learned and used by agastroenterologist, or another non-surgical specialist, rather thanbeing suited moreso for a colorectal surgeon with specialized training;(iv) is gentle for at least the reason that it does not require cutting,banding, and/or stapling for the removal, and/or intentional necrosisof, rectal tissue; (v) gently secures the rectal tissue with acontrolled or limited pressure and for a limited time to avoid tissuedamage during the occluding of a vascular supply to a hemorrhoid; and,as a result, (vi) facilitates an ischemic regression of a hemorrhoidwith substantially less post procedural pain than the current procedureswhich are directed to a traumatic removal or necrosis of the rectaltissue. Those skilled in the art, and also the patients receivinghemorrhoid treatments, will appreciate having such a simple andcost-effective method of gently obtaining (vii) a loss of bulk andweight in the hemorrhoid without the unnecessary trauma and increasedpost-procedural pain in the patient that is now commonplace in the art.

SUMMARY

The teachings provided herein are directed to methods and devices fortreating a hemorrhoid in a subject in a manner that producessubstantially less post-procedural pain in the subject, the methodavoiding a removing or a necrosis of a rectal tissue.

The teachings include a method of treating a hemorrhoid while minimizingtissue damage and substantially reducing post-procedural pain. Generallyspeaking, the method includes identifying a rectal tissue that comprisesa vascular supply to a hemorrhoid, folding the rectal tissue to create afold, securing the fold, and occluding the vascular supply to thehemorrhoid to facilitate an ischemic regression of the hemorrhoid,wherein the folding, securing, and occluding are all done gently toavoid a removal and/or a necrosis of the rectal tissue. The method caninclude inserting a therapeutic anoscope into an anus of a subjecthaving the hemorrhoid, the anoscope operable to (i) form a fold in arectal tissue orally to the hemorrhoid and above a dentate line in thesubject; (ii) gently secure the fold; (iii) create a work space abovethe dentate line; and, (iv) provide a visualization of the rectal tissuewithout an image transmission through optic fibers.

The method can include gently securing the fold in the rectal tissueusing a limited pressure to avoid a removal or a necrosis of the rectaltissue, the fold having the vascular supply for the hemorrhoid. Finally,the method can include occluding the vascular supply to the hemorrhoidin a targeted manner to otherwise minimize damage to the rectal tissue,the occluding including a component selected from the group consistingof heat, energy, or ligation. In addition to the other benefitsset-forth herein, the gentle methods provided by the teachings canresult in substantially less post-operative pain than a method oftreating hemorrhoids that does not avoid the removal or the necrosis ofthe rectal tissue. The terms “minimize,” “minimizing,” “minimized,”“avoid,” “avoiding,” “avoided,” can be used interchangeably in someembodiments. Tissue damage can be minimized or avoided, for example,where a procedure is directed to reducing an amount of any unnecessarytissue damage that may otherwise be associated with a procedure. Thegentle procedures taught herein, for example, are directed to preservingtissue during a hemorrhoid treatment by avoiding or minimizing theremoval or the necrosis of the rectal tissue fold from the gentleprocedures that lead to the tissue-preserving ischemic regressions ofhemorrhoidal tissue.

It should be appreciated that the methods can be used to treat most anycondition that could benefit from an ischemic regression of ahemorrhoid. For example, the methods can further comprise preventing,inhibiting, reducing, or eliminating a prolapse of the hemorrhoid.

The anoscope used in the methods can comprise a cylindrical, orsubstantially cylindrical, body for insertion into the subject, thecylindrical body creating a work space having a sufficient volume toperform the occluding of the vascular supply to the hemorrhoid. In suchembodiments, the cylindrical, or substantially cylindrical, bodycomprises a side window and a convex surface that promotes an entry ofthe rectal tissue into the window for the gently securing of the rectaltissue.

The methods can include the use of a limited pressure on the rectaltissue for the gently securing of the fold, such that the tissue damageis minimized or avoided, prevented, or substantially prevented. In someembodiments, the limited pressure can range from, for example, about 50kPa to about 500 kPa. Any system known to one of skill in the art can beused to control the amount of pressure applied to the tissue. Forexample, in some embodiments, the limited pressure can be obtained fromthe use of a spring-regulated pressure that facilitates the gentlysecuring of the fold.

The methods can include occluding the vascular supply to the hemorrhoidin a targeted manner to avoid unnecessary tissue damage. In someembodiments, the targeted manner includes gently securing the fold intoa constant tissue fold configuration for a suturing to selectivelyligate the vascular supply during the occluding while otherwise avoidingthe removal or the necrosis of the rectal tissue.

The occluding can be achieved using any method known to one of skill, tothe extent that the method is gentle enough to avoid trauma to thepatient in a manner consistent with the teachings herein. The occluding,for example, can include a selective and focused application of heat,energy, or ligation to the vascular supply to the hemorrhoid, theapplication limited to occluding the vascular supply while otherwiseminimizing damage to the tissue. As such, the method can be applied in atargeted manner to minimized trauma to the patient. In some embodiments,the targeted manner can include heating at a temperature of about 50° C.to about 65° C. for an effective time to selectively coagulate thevascular supply during the occluding while avoiding the removal or thenecrosis of the rectal tissue fold. In some embodiments, the targetedmanner includes heating at a temperature of about 50° C. to about 65° C.for an effective time, the heating including applying an energy from aplurality of discrete regions on the pinching surfaces to acorresponding plurality of discrete areas on the fold to selectivelycoagulate the vascular supply during the occluding while preserving theremainder of the fold to avoid the removal or the necrosis of the rectaltissue fold.

The methods can include gently securing a fold of rectal tissuecomprising the vascular supply to the hemorrhoid, and the gentlysecuring can include any method known to one of skill that is gentleenough to avoid unnecessary trauma to the patient in a manner consistentwith the teachings herein. The gentle securing can be used to create aconstant tissue fold configuration to facilitate the occluding of thevascular supply to the hemorrhoid. The teachings provided herein includea means for securing the fold with a controlled pressure to provide theconstant tissue fold configuration.

The controlled pressure can come from any configuration or orientationthat gently secures the fold. In some embodiments, the body of theanoscope has a central axis, and the controlled pressure is applied atan angle ranging from about 0 degrees to about 90 degrees from thecentral axis. In some embodiments, the orientation in which thecontrolled pressure is applied can be adjusted in the anoscope. In someembodiments, the adjusting of the orientation can be done outside of thepatient's body and, in some embodiments, after insertion of the anoscopeinto the patient's body.

The teachings are also directed to the therapeutic anoscopes. In someembodiments, the anoscope for treating a hemorrhoid in a subject can bedesigned to avoid trauma associated with removing a rectal tissue. Theanoscope can include a cylindrical, or substantially cylindrical,anoscope body having a lumen, a proximal opening, a distal endconfigured for a first point of entry into an anus of a subject, and aside window having a shutter and pinching surfaces to form a fold in arectal tissue orally to a hemorrhoid. The pinching surfaces can beconfigured to gently secure the fold with a limited pressure above adentate line in a subject. The anoscope body can have any configurationthat will support a mechanism that will operably function with themethods taught herein. In some embodiments, the anoscope body can beconfigured for providing a length sufficient to position the pinchingsurfaces above the dentate line in the subject. And, in someembodiments, the anoscope body can be configured for providing a volumein the lumen sufficient for receiving the fold of the rectal tissue forthe occluding of the vascular supply to the hemorrhoid. In someembodiments, the shutter can be configured for opening the window toallow the rectal tissue to enter the window during the treatment of thehemorrhoid in the subject; creating the fold in the rectal tissue orallyto the hemorrhoid; and, gently securing the fold with the limitedpressure above the dentate line to avoid the removal or the necrosis ofthe rectal tissue that creates the trauma to the subject. The anoscopecan be configured to (i) provide a visualization of the rectal tissuewithout an image transmission through optic fibers and (ii) facilitatean ischemic regression of the hemorrhoid through the occluding to treatthe hemorrhoid in a manner that provides substantially less postprocedural pain to the subject than a hemorrhoid treatment procedurethat does not avoid the removal or the necrosis of the rectal tissue.

In some embodiments, the anoscope includes a means for securing the foldwith a controlled pressure to provide a constant tissue foldconfiguration, the means including the structures taught herein, andvariations that have substantially the same structure, that perform thegentle securing of tissue that is taught herein. In some embodiments,the anoscopes gently secure the tissues using limited pressure rangingfrom about 50 kPa to about 1000 kPa.

In some embodiments, the volume is sufficient for a suturing toselectively ligate the vascular supply during the occluding whileotherwise avoiding the removal or the necrosis of the rectal tissue.And, in some embodiments, the volume is sufficient for an application ofheat at a temperature of about 50° C. to about 65° C. for an effectivetime to selectively coagulate the vascular supply during the occludingwhile avoiding a necorsis of the rectal tissue fold. Moreover, in someembodiments, the volume is sufficient for an application of an RF energyto selectively coagulate the vascular supply during the occluding whileavoiding a necrosis of the rectal tissue fold. In some embodiments, theRF energy or heat can be applied such that the temperature is ramped ata desired rate and heated for an effective amount of time to occlude thevascular supply to the hemorrhoid while otherwise minimizing damage totissue surrounding the vascular supply.

In some embodiments, the anoscope body has a central axis, and thelimited pressure is applied in the same, or substantially same, plane asa plane formed by the rectal tissue fold before the pinching, and at anangle ranging from about 0 degrees to about 90 degrees from the centralaxis. And, in some embodiments, the anoscope body can be at leastpartially translucent or transparent to facilitate viewing of a tissue,for example.

In some embodiments, a therapeutic anoscope is presented for treating aprolapsed hemorrhoid in a subject in a manner that creates substantiallyless post-procedural pain. The anoscope can have a cylindrical, orsubstantially cylindrical, anoscope body having a lumen, a proximalopening, a distal end configured for a first point of entry into an anusof a subject. The body can also include a side window having a shutterand pinching surfaces to form a fold in a rectal tissue orally to aprolapsed hemorrhoid and gently secure the fold with a limited pressureabove a dentate line in a subject. The anoscope body can be configuredfor providing a length sufficient to position the pinching surfacesabove the dentate line in the subject; and, providing a volume in thelumen sufficient for receiving the fold of the rectal tissue for anoccluding of a vascular supply to the hemorrhoid. The shutter can beconfigured for opening the window to allow the rectal tissue to enterthe window during a treatment of a hemorrhoid in the subject; creatingthe fold in the rectal tissue orally to the prolapsed hemorrhoid; and,gently securing the fold with a limited pressure ranging from about 50kPa to about 1000 kPa above the dentate line to avoid a removal or anecrosis of the rectal tissue that creates a significant trauma to thesubject. It should be appreciated that, in some embodiments, the rectaltissue can incorporate at least a portion of a hemorrhoid in a rectaltissue fold where, in some embodiments, the entire hemorrhoid may beincorporated. And, the anoscope can function to (i) directly visualizethe rectal tissue without an endoscope having optic fibers and (ii)facilitate an ischemic regression of the prolapsed hemorrhoid throughthe occluding. The anoscopes taught herein can be used to treat thehemorrhoid in a manner that provides substantially less post proceduralpain to the subject than a procedure that does not avoid the removal orthe necrosis of the rectal tissue that creates trauma to the subject,facilitating the ischemic regression that results in a loss of bulk andweight in the prolapsed hemorrhoid.

It should be appreciated that the pinching surfaces that gently securethe tissue can have any configuration known to one of skill toaccomplish the act of gently securing, for example, the fold of tissuefor the occluding of the vascular supply to the hemorrhoid. Theconfiguration should provide a securing surface and pressure that isgentle enough to avoid or minimize trauma to the patient in a mannerconsistent with the teachings herein. In some embodiments, the pinchingsurfaces can have an arcuate shape to facilitate a recruiting of therectal tissue into the lumen of the body of the anoscope. And, in someembodiments, the pinching surfaces have a plurality of discrete regionson the pinching surfaces corresponding to a plurality of discrete areason the fold to selectively coagulate the vascular supply during theoccluding while preserving the remainder of the fold to avoid theremoval or the necrosis of the rectal tissue.

The teachings are directed to a system for treating a hemorrhoid in asubject in a manner that creates substantially less post-proceduralpain. In some embodiments, the system comprises a therapeutic anoscopeas taught herein; and, an occlusion device operable for a targetedapplication of heat, energy, or ligation to the vascular supply to thehemorrhoid, the targeted application otherwise avoiding damage to therectal tissue. In some embodiments, the occlusion device applies RFenergy to the vascular supply to the hemorrhoid. In some embodiments,the occlusion device facilitates an application of a suture to thevascular supply to the hemorrhoid. And, in some embodiments, theocclusion device applies heat to the vascular supply to the hemorrhoidat a temperature ranging from about 50° C. to about 65° Cfor aneffective time to selectively coagulate the vascular supply during theoccluding while avoiding a necrosis of the rectal tissue fold.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an anus and rectum of a subject having an internalhemorrhoid and an external hemorrhoid, according to some embodiments.

FIGS. 2A-2C illustrate state-of-the-art treatment methods that producesignificantly more post-procedural pain than the gentle treatmentsset-forth herein.

FIGS. 3A-3F illustrate a method of treating a prolapsed hemorrhoid,according to some embodiments.

FIGS. 4A-4F illustrate the occlusion of the vascular supply to thehemorrhoid that leads to the ischemic regression of the hemorrhoidaltissue, according to some embodiments.

FIGS. 5A-5C illustrate a method and device for gently securing andsuturing a fold of rectal tissue above a dentate line and orally to ahemorrhoid, according to some embodiments.

FIGS. 6A-6D illustrates a therapeutic anoscope for treating a hemorrhoidin a subject while avoiding a trauma associated with removing a rectaltissue, according to some embodiments.

FIGS. 7A and 7B illustrate an exploded view of therapeutic anoscopeswith and without components for delivering energy for occlusion of avascular supply to a hemorrhoid, according to some embodiments.

FIGS. 8A-8F illustrate aspects of therapeutic anoscopes with and withoutcomponents for delivering energy for occlusion of a vascular supply to ahemorrhoid, according to some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

The teachings provided herein are directed to methods and devices fortreating a hemorrhoid in a subject in a manner that producessubstantially less post-procedural pain in the subject, the methodavoiding a removing or a necrosis of a rectal tissue.

FIG. 1 illustrates an anus and rectum of a subject having an internalhemorrhoid and an external hemorrhoid, according to some embodiments.The rectum 105 and anus 110 are separated by a dentate line 115. Theinternal hemorrhoid 120 is enlarged and is located below the dentateline 115, and external hemorrhoid 125 is located exterior to the anus110. Both the internal hemorrhoid 120 and the external hemorrhoid 125are masses of vascular tissue that can bleed, itch, and be painful tothe subject. Hemorrhoids can be classed as “early” or “advanced,” wherethe early hemorrhoids further classed as “grade I” or “grade II”hemorrhoids, and the advanced hemorrhoids are further classed as “gradeIII” or “grade IV” hemorrhoids. Grade I hemorrhoids bleed but do notprolapse outside the anal canal. Grade II hemorrhoids can suffer a mildprolapse and retract spontaneously. Grade III hemorrhoids can prolapseand require manual replacement into the anal canal. Grade IV hemorrhoidscan be prolapsed tissue that can no longer be manually replaced. Astissue becomes redundant and/or suspensory ligaments weaken, thehemorrhoid and/or lower rectal tissues, whether mucosal or submucosal,can prolapsed outside the rectum causing bleeding, pain, and discomfort.There are about 13.2 million people with symptomatic hemorrhoids in theUS only, and over 1 million new cases are diagnosed annually.

It should be appreciated by one of skill that the teachings set-forthherein can also be useful, in some embodiments, in the treatment ofother superficial lesions, lesions other than hemorrhoids in someembodiments. Such lesions can include, but are not limited to rectalmucosal polyps, warts, and radiation proctitis.

The teachings provided herein are also directed to a method of treatinga hemorrhoid while minimizing tissue damage and substantially reducingpost-procedural pain. Generally speaking, the methods can includeidentifying a rectal tissue that comprises a vascular supply to ahemorrhoid, folding the rectal tissue to create a fold, securing thefold, and occluding the vascular supply to the hemorrhoid to facilitatean ischemic regression of the hemorrhoid, wherein the folding, securing,and occluding are all done gently to avoid a removal and/or a necrosisof the rectal tissue. As such, one of skill will appreciate havinggentle methods of treatment that result in substantially lesspost-procedural pain over existing, state-of-the-art treatments. One ofskill will appreciate that early hemorrhoids are often currently treatedusing rubber banding devices and infrared coagulation, for example, andadvanced hemorrhoids are often currently treated using staples orDoppler-guided suture-based techniques, such as the popular PPHprocedure (Procedure for Prolapse and Hemorrhoids) that respectivelyexcises or suture-ligates the superior hemorrhoidal blood supply andpulls the prolapsed hemorrhoidal tissue into the anal canal.

The term “substantially” can be used, for example, to refer to an amountthat one of skill would consider to be marked improvement over thecomparison. In some embodiment, a substantial improvement can be agreater that 20%. In some embodiments, a substantial improvement can begreater than 30%, 40%, or 50%. In some embodiments, a substantialimprovement can be greater than 60%, 70%, or 80%. And, in someembodiments, a substantial improvement can be greater than 90%, 95%, or99%. Also, the perception of pain varies significantly from patient topatient, depending on culture, gender, age, social status, previousexperience with pain, and other factors. Without intending to be limitedto any theory or mechanism of action, what is mild discomfort or “nopain” for one person, could be expressed as painful or somewhat painfulby another, etcetera. As a result, it should also be appreciated thatone of skill could consider a post-procedural sensation to be“relatively painless,” for example, when the majority of the patients,such as greater than 50%, 60%, 70%, or 80% of the patients in someembodiments, define or describe the sensation as painless including, forexample, a sensation without pain or a sensation having mild-to-moderatediscomfort only.

The PPH method is an example of a procedure that, although popular,creates a substantial trauma to the subject, and often much more traumathan is needed to treat a target area having a small lesion. Theprocedure includes pulling prolapsed tissue into a device for excision,the device having circular stapling mechanism for stapling the remainingunexcised tissue circumferentially around the target region of therectoanal region having the hemorrhoid. And, this circumferential traumais required by this technique, even if the pathology is focal. As aresult, there are substantial risks with this method that include, forexample, (i) the substantial trauma that creates a substantial amount ofpost-procedural pain; (ii) pulling too much muscle tissue into thedevice and excising the muscle with the hemorrhoid; (iii) sepsis fromthe trauma; and (iv) the possibility of chronic pain and chronic fecalurgency after the procedure. The PPH procedure is an example of aprocedure that is not only significantly traumatic to the patient and,as a result, is typically performed by a colorectal surgeon, but it'salso capital intensive. Once popular, this method has a growing disfavorin the surgical community. Suture-based devices are in development, asthey can be effective with less pain, but these still suffer the needfor high capital equipment, a steep learning curve, and for at leastthese reasons, a growing disfavor among surgeons.

FIGS. 2A-2C illustrate state-of-the-art treatment methods that producesignificantly more post-procedural pain than the gentle treatmentsset-forth herein. FIG. 2A illustrates a rubber band ligation 205, whichincludes a strangulation of a small portion of the hemorrhoid 210 with arubber band 215. The method uses an anoscope 220 with a rubber banddelivery device 225. As with the PPH procedure, there is substantialpost-procedural pain for about 5-7 days, substantial discomfort in thesubject, a limited success rate, and is a procedure that is consideredtedious with a steep learning curve and, as a result, is typicallyperformed by a colorectal surgeon. FIG. 2B illustrates an infraredcoagulation method that uses an endoscope 240 and an energy deliverydevice 245, the system 250 of which can be considered capital intensiveand cumbersome. In addition, such methods are considered ineffective,being labeled as a method of “shooting-in-the-dark” with a small focusof energy 255 at a small and hard-to-locate target 260 for treatment ofthe hemorrhoid 210. FIG. 2C illustrates a heat and energy based methodthat is designed for a direct destruction of the hemorrhoid 210 with amonopolar electrical probe 280. As with other the state-of-the-artmethods, the destruction creates an excessive tissue trauma, andsignificant pain to the subject. Moreover, the procedure requires aprolonged, tedious application time of about 15 minutes to about 30minutes, as well as high capital equipment costs.

FIGS. 3A-3F illustrate a method of treating a prolapsed hemorrhoid,according to some embodiments. As shown in FIG. 3A, internal hemorrhoids320,321 are forming in a subject 301 in the subject's rectum 305 orallyto the dentate line 315. FIG. 3B shows the manner in which an internalhemorrhoid 320 can become mobile and move toward the anus 310 due to thebulk and weight of the increased volume of blood 322 in the vasculatureof the hemorrhoid 320. FIG. 3C shows the internal hemorrhoid 320 afterit has prolapsed exterior to the anus 310. FIG. 3D shows the insertionof a therapeutic anoscope 350 as taught herein. The anoscope 350includes a window 355 having a shutter 360 that is positioned orally tothe dentate line 315 and opened for an entry of rectal tissue 365 intothe lumen 370 of the anoscope 350.

The method can include inserting the anoscope 350 into the anus 310 ofthe subject 301 having the hemorrhoid 320, the anoscope 350 operable for(i) forming a fold 375 in the rectal tissue 365 orally to the hemorrhoid320 and above the dentate line 315 in the subject 301; (ii) gentlysecuring the fold 375; (iii) creating a work space 380 above the dentateline 315; and, (iv) providing a visualization 385 of the rectal tissue365 without use of other apparatus such as, for example, an imagetransmission through optical fibers. As shown in FIG. 3F, the method caninclude gently securing the fold 375 in the rectal tissue 365 using alimited pressure between pinching surfaces 356,361 created by theshutter 360 and the window 355 to avoid a removal or a necrosis of therectal tissue 365, the fold 375 having the vascular supply 399 for thehemorrhoid 320. Finally, the method can include occluding the vascularsupply 399 to the hemorrhoid in a targeted manner to otherwise avoiddamage to the rectal tissue 365, the occluding including a componentselected from the group consisting of heat, energy, ligation, or acombination thereof. In addition to the other benefits set-forth herein,the gentle methods provided can result in substantially lesspost-operative pain than a method of treating hemorrhoids that does notavoid the removal or the necrosis of the rectal tissue. As shown inFIGS. 3A-3F, the methods can be used to treat most any condition thatcould benefit from an ischemic regression of a hemorrhoid, including thepreventing, inhibiting, reducing, or eliminating of a prolapse of thehemorrhoid.

The methods can include gently securing a fold of rectal tissuecomprising the vascular supply to the hemorrhoid, and the gentlysecuring can include any method known to one of skill that is gentleenough to avoid a significant trauma to the patient while effectiveenough to obtain the occlusion of the vascular supply to the hemorrhoidthat leads to the ischemic regression of the hemorrhoidal tissue. Theterm “effective,” can be used to describe an amount or a result thatobtains, either in full or at least substantially, a desired outcome.For example, if an ischemic regression of a tissue is sought through anocclusion of a vascular supply to the tissue, the occlusion can beconsidered effective where there is at least some ischemic regression,at least in some embodiments. In some embodiments, the outcome can be atleast substantially obtained where there is a desired reduction in thedegree or extent of symptoms present. For example, a desired reductioncan be substantial, in some embodiments, where the degree or extent ofsymptoms is reduced by 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, orany 5% increment therein. In some embodiments, an outcome can be atleast substantially obtained where the outcome is obtained in areasonable amount of time. A reasonable amount of time may be, forexample, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, or thelike, depending on the type and extent of outcome desired.

FIGS. 4A-4F illustrate the occlusion of the vascular supply to thehemorrhoid that leads to the ischemic regression of the hemorrhoidaltissue, according to some embodiments. As shown in FIG. 4A, the gentlysecuring can be used to create a constant tissue fold configuration 402to facilitate the occluding of the vascular supply 499 to the hemorrhoid420. FIG. 4A also shows a means for securing the fold 475 with acontrolled pressure using the therapeutic anoscope 450 to provide theconstant tissue fold configuration 402 to the rectal tissue 465. Thestructure of the means can include opposing pinching surfaces 456, 461having, for example a distal contact surface 456 of the window 455 thatis opposing a distal contact surface 461 of the shutter 460. Thecontrolled pressure 403 can be provided by any means for controlling thepressure, or force per unit area, applied to the rectal tissue 465. Theterms “controlled” and “limited” can be used interchangeably, in someembodiments. In some embodiments, a pressure is “controlled” where theuser has substantial control over the amount of pressure applied, andthe type of control can include a variety of control mechanisms known toone of skill. In some embodiments, a pressure is “limited” where thereis a pressure- governing mechanism in place, and the type of governingcan include a variety of governing mechanisms known to one of skill. Itshould be appreciated that pressure can be regulated as any form ofpressure, for example, mechanical, pneumatic, hydraulic, or the like,where one of skill can control or limit pressure using known methods.

The methods can include the use of a limited pressure on the rectaltissue for the gently securing of the fold, such that the tissue damageis avoided, prevented, or substantially prevented. Any mechanism knownto one of skill in the art can be used to control or limit the amount ofpressure applied to the tissue to avoid damage to the tissue. In someembodiments, a means for controlling the pressure, or force per unitarea, can include, for example, a spring mechanism that limits thepressure applied to the rectal tissue 465 to what is applied by thespring to the pinching surfaces 456,461, the spring preventing a userfrom applying a pressure greater than the pressure that creates acompression of the spring. In some embodiments, a means for controllingthe pressure, or force per unit area, can include, for example, amaterial having a modulus of elasticity that prevents a user fromapplying a pressure greater than the pressure that creates a strain ofthe material. In some embodiments, a means for controlling the pressure,or force per unit area, can include, for example, a material having ahardness that prevents a user from applying a pressure greater than thepressure that creates a compression of the material. In someembodiments, a component in the anoscope or treatment system includingthe anoscope, can include any one or any combination of such pressurelimiting systems.

The methods can include occluding the vascular supply to the hemorrhoidin a targeted manner to avoid unnecessary tissue damage. The occludingcan be achieved using any method known to one of skill, to the extentthat the method is gentle enough to avoid trauma to the patient whileeffective enough to obtain the ischemic regression of the hemorrhoidaltissue. The occluding, for example, can include a selective and focusedapplication of heat, energy, ligation, or a combination thereof, to thevascular supply to the hemorrhoid, the application limited to occludingthe vascular supply while otherwise avoiding damage to the tissue. Assuch, the method can be applied in a targeted manner to avoid trauma tothe patient.

FIG. 4B shows the application of heat 444 to the rectal tissue 465 incombination with the gently securing of the rectal tissue 465. FIG. 4Cshows the vascular supply 499 after the gently securing, still flowingvenous and arterial blood through the fold 402 and to the hemorrhoid420, after which the heat 444 is applied for the occlusion 455 of theblood flow 477. FIG. 4E shows an ischemic regression 466 of thehemorrhoid 420 after the occlusion 455 has been obtained. The fold 475remains in place and regresses over time as well, as shown in FIG. 4F.FIG. 4F illustrates a successful treatment.

The pressure used to gently secure the fold can vary according to anumber of factors. One of skill will appreciate, for example, that notall tissue will respond to pressure in the same manner, as there arevariations within and between subjects due to any number of reasonsknown in the art, including heterogeneity of tissue within and betweenpatients, the age of the patient, the patient's health and/or conditiontreated, and the like. And, it will be appreciated that the response oftissue to increases in pressure may not be linear, in some embodiments,as increased forces applied to small contact areas may causeproportionally more damage to tissue when compared to equal pressuresapplied to the same tissue using relatively larger contact areas.Likewise, temperature can have an effect, as the application of pressureto a tissue can show an increased amount of damage to the tissue whenthe pressure is applied at an increased temperature.

In some embodiments, the limited pressure can range from, for example,about 50 kPa to about 1000 kPa, about 50 kPa to about 750 kPa, about 50kPa to about 500 kPa, about 75 kPa to about 800 kPa, about 100 kPa toabout 600 kPa, about 100 kPa to about 300 kPa, about 50 kPa to about 400kPa, about 50 kPa to about 250 kPa, about 25 kPa to about 500 kPa, about500 kPa to about 1000 kPa, about 500 kPa to about 750 kPa, about 750 kPato about 1000 kPa, or any range therein. In some embodiments, thelimited pressure can be about 10 kPa, about 20 kPa, about 30 kPa, about40 kPa, about 50 kPa, about 60 kPa, about 70 kPa, about 80 kPa, about 90kPa, about 100 kPa, about 110 kPa, about 120 kPa, about 130 kPa, about140 kPa, about 150 kPa, about 160 kPa, about 170 kPa, about 180 kPa,about 190 kPa, about 200 kPa, 210 kPa, about 220 kPa, about 230 kPa,about 240 kPa, about 250 kPa, about 260 kPa, about 270 kPa, about 280kPa, about 290 kPa, about 300 kPa, 310 kPa, about 320 kPa, about 330kPa, about 340 kPa, about 350 kPa, about 360 kPa, about 370 kPa, about380 kPa, about 390 kPa, about 400 kPa, about 500 kPa, about 600 kPa,about 700 kPa, about 800 kPa, about 900 kPa, about 1000 kPa, or any 5kPa increment therein.

In some embodiments, a contact area of a pinching surface can range fromabout 20 mm² to about 1000 mm^(2,) from about 20 mm² to about 1000 mm²,from about 40 mm² to about 800 mm², from about 50 mm² to about 500 mm²,from about 75 mm² to about 750 mm², from about 90 mm² to about 900 mm²,from about 100 mm² to about 300 mm², from about 175 mm² to about 400mm², from about 200 mm² to about 500 mm², from about 40 mm² to about 400mm²from about 45 mm² to about 450 mm², from about 50 mm² to about 100mm², or any range therein. In some examples the contact area of apinching surface can be, for example, about 50 mm², about 60 mm², about70 mm², about 80 mm², about 90 mm², about 100 mm², about 110 mm², about120 mm², about 130 mm², about 140 mm², about 150 mm², about 160 mm²,about 170 mm², about 180 mm², about 190 mm², about 200 mm², about 210mm², about 220 mm², about 230 mm², about 240 mm², about 250 mm², about260 mm², about 270 mm², about 280 mm², about 290 mm², about 300 mm², orany 5 mm² increment therein.

In some embodiments, the force applied to a contact area can range fromabout 100 g to about 5000 g, from about 200 g to about 4000 g, fromabout 300 g to about 3000 g, from about 200 g to about 2000 g, fromabout 300 g to about 1000 g, from about 500 g to about 1000 g, or anyrange therein. In some embodiments, the force can be about 200 g, 300 g,400 g, 500 g, 600 g, 700 g, 800 g, 900 g, 1000 g, 1100 g, 1200 g, 1300g, 1400 g, 1500 g, 1600 g, 1700 g, 1800 g, 1900 g, 2000 g, 2100 g, 2200g, 2300 g, 2400 g, 2500 g, 2600 g, 2700 g, 2800 g, 2900 g, 3000 g, 3100g, 3200 g, 3300 g, 3400 g, 3500 g, 3600 g, 3700 g, 3800 g, 3900 g, 4000g, or any 10 g increment therein.

In some embodiments, the targeted manner can include heating at atemperature of about 50° C. to about 65° C. for an effective time toselectively coagulate the vascular supply during the occluding whileavoiding the removal or the necrosis of the rectal tissue. In someembodiments, the targeted manner includes heating at a temperature ofabout 50° C. to about 65° C. for an effective time, the heatingincluding applying an energy from a plurality of discrete regions on thepinching surfaces to a corresponding plurality of discrete areas on thefold to selectively coagulate the vascular supply during the occludingwhile preserving the remainder of the fold to avoid the removal or thenecrosis of the rectal tissue fold. In some embodiments, the heating canbe at a temperature ranging from about 30° C. to about 70° C., fromabout 35° C. to about 65° C., from about 40° C. to about 60° C., fromabout 45° C. to about 55° C., from about 50° C. to about 65° C., or anyrange therein. In some embodiments, heating can be at a temperature ofabout 40° C., about 45° C., about 50° C., about 55° C., about 60° C.,about 65° C., about 70° C., or any 1° C. increment therein.

The heating can be applied for a limited amount of time, or obtained orapplied by ramping to the temperature over a period of time.Accordingly, the temperature can be applied as a constant temperaturefor an effective time, a ramping to a temperature over an effectivetime, a ramping to a temperature that is applied for an effective time,a ramping down from a temperature, or any combination thereof. One ofskill will appreciate that the selection of the desired temperature/timeprocedure for applying an occlusion energy, for example, will be afunction of occluding the vascular supply to the hemorrhoid mosteffectively with the least tissue damage. In some embodiments, theheating can be applied for a time ranging from about 1 sec to about 120seconds, from about 5 sec to about 90 seconds, from about 10 sec toabout 60 seconds, from about 5 sec to about 30 seconds, from about 1 secto about 5 seconds, from about 5 sec to about 10 seconds, from about 10sec to about 30 seconds, or any range therein. In some embodiments theramping time to a temperature can range from about 1 sec to about 120seconds, from about 5 sec to about 90 seconds, from about 10 sec toabout 60 seconds, from about 5 sec to about 30 seconds, from about 1 secto about 5 seconds, from about 5 sec to about 10 seconds, from about 10sec to about 30 seconds, or any range therein. An “effective amount oftime” or an “effective time” is the amount of time that produces adesired extent of occlusion of the vascular supply to the hemorrhoid. Insome embodiments, the vascular supply can be occluded during aneffective amount of time by 75%, 80%, 85%, 90%, 95%, 97%, 99%, 100%, orany 1% increment therein. In some embodiments, the effective amount oftime can result in less than 100% occlusion, and the vascular supplyreaches 100% occlusion without further therapy. In some embodiments,less than 100% occlusion is desired during the effective time to avoidunnecessary damage to tissue and still achieve ischemic regression ofthe hemorrhoid.

The application of heat and/or energy in the occlusion can be absent insome embodiments. In some embodiments, for example, the targeted mannerincludes gently securing the fold into a constant tissue foldconfiguration for a suturing of the rectal tissue orally to thehemorrhoid to selectively ligate the vascular supply to the hemorrhoid.A careful suturing that otherwise avoids the removal or the necrosis ofthe rectal tissue again avoids damage to the tissue, substantiallyreducing trauma and an associate post-procedural pain to the patient. Insome embodiments, however, the suturing can be accompanied by anapplication of heat and/or energy as taught herein.

FIGS. 5A-5C illustrate a method and device for gently securing andsuturing a fold of rectal tissue above a dentate line and orally to ahemorrhoid, according to some embodiments. FIGS. 5A and 5B illustrate atherapeutic anoscope 550 operable for (i) forming a fold 575 in therectal tissue 565 orally to the hemorrhoid 520 and above the dentateline 515 in the subject 501; (ii) gently securing the fold 575; (iii)creating a work space 580 above the dentate line 515; and, (iv)providing a visualization 585 of the rectal tissue 565 without use ofother apparatus such as, for example, an image transmission throughoptical fibers. As shown in FIG. 5B, the method can include gentlysecuring the fold 575 in the rectal tissue 565 using a limited pressurebetween pinching surfaces 556, 561 created by the shutter 560 and thewindow 555 to avoid a removal or a necrosis of the rectal tissue 565,the fold 575 having the vascular supply 599 for the hemorrhoid 520.Finally, FIG. 5C shows that the method can include occluding thevascular supply 599 to the hemorrhoid in a targeted manner to otherwiseavoid damage to the rectal tissue 565, the occluding 555 including asuturing 569 to ligate the vascular supply 599 and stop or reduce theflow of blood 577 to ischemically regress the hemorrhoid 520. Theanoscope is shown in FIG. 5A as having a proximal handle 509 and adistal handle 511 operably attached to the shutter 560, the proximalhandle 509 slidably attached to the distal handle 511, such that thelongitudinal axis 560 a of the shutter 560 slides in a direction that isparallel or substantially parallel to the longitudinal axis 512 a of thebody 512 of the anoscope 550. The longitudinal axis 509 a of theproximal handle 509 and/or the longitudinal axis 511 a of the distalhandle 511 can be in a pistol-grip orientation to the longitudinal axis512 a of the body 512 to allow for a comfortable grip and manipulationof the anoscope 550 during use.

The controlled or limited pressure, or force per unit area, can comefrom any configuration or orientation that gently secures the fold. Insome embodiments, the body of the anoscope has a central axis, and thecontrolled pressure is applied at an angle ranging from about 0 degreesto about 90 degrees from the central axis. In some embodiments, theorientation in which the controlled pressure is applied can be adjustedin the anoscope. In some embodiments, the adjusting of the orientationcan be done outside of the patient's body and, in some embodiments,after insertion of the anoscope into the patient's body, for example, insitu during a procedure to avoid a need to remove, adjust, and re-insertthe therapeutic anoscope.

The teachings are also directed to a anoscope used with the methodstaught herein. An anoscope used in the methods can comprise anyscaffolding structure and means for performing the steps of the methodsdescribed herein, namely identifying a rectal tissue that comprises avascular supply to a hemorrhoid, folding the rectal tissue to create afold, securing the fold, and occluding the vascular supply to thehemorrhoid to facilitate an ischemic regression of the hemorrhoid,wherein the folding, securing, and occluding are all done gently toavoid a removal and/or a necrosis of the rectal tissue. For example, anymeans for creating the work space in the subject can be fashioned foruse as an anoscope, and any means for gently securing a fold of tissuedorally to the hemorrhoid and above the dentate line can also be used inthe occluding. The means for creating the work space can be, forexample, a static or dynamically expandable framework of panels orstruts, an inflatable scaffolding, a rigid cylinder, a transparentstructure, and the like, the scaffolding having a means for receiving arectal tissue to facilitate gently securing a fold in the rectal tissuefor gently occluding the vascular supply to the hemorrhoid. In someembodiments, the work space can be creating using a cylindrical, orsubstantially cylindrical, body for insertion into the subject, thecylindrical body creating a work space having a sufficient volume toperform the occluding of the vascular supply to the hemorrhoid. In suchembodiments, the cylindrical, or substantially cylindrical, body cancomprise a side window and, optionally, a convex surface or bulge thatcan be designed to help promote an entry of the rectal tissue into thewindow for the gently securing of the rectal tissue. In someembodiments, the body of the anoscope is operably attached to a distalhandle, and the distal handle is operable attached to a proximal handle,the proximal handle being operably attached to a shutter component forclosing the window and applying a controlled, or limited, pressure to arectal tissue. Consistent with the teachings herein, the controlled, orlimited, pressure is a design feature that's incorporated by mechanism,materials, or a combination thereof, into the anoscope to avoid applyingan amount of pressure that unnecessarily creates tissue damage. In someembodiments, the anoscope can have a pistol-grip configuration, as shownin FIG. 5A, for example, making the device easy for a user to hold andmanipulate during a treatment. A pistol-grip configuration can beconfigured, for example, such that the longitudinal axis of the proximaland/or distal handle can have an angle with the axis of the body that isabout 20°, about 25°, about 30°, about 35°, about 40°, about 45°, or any1° increment therein.

FIGS. 6A-6D illustrates a therapeutic anoscope for treating a hemorrhoidin a subject while avoiding a trauma associated with removing a rectaltissue, according to some embodiments. The therapeutic anoscope 650 caninclude a cylindrical, or substantially cylindrical, anoscope body 612having a lumen 614, a proximal opening 616, a distal end 618 configuredfor a first point of entry into an anus of a subject, and a side window655 having a shutter 660 and pinching surfaces 656,661 to form a fold ina rectal tissue orally to a hemorrhoid. The pinching surfaces 656,661can be configured to gently secure the fold 575 with a limited pressureabove a dentate line in a subject. The anoscope body 612 can have anyconfiguration that will support a visualization, and a gentle tissuecapturing and securing mechanism that will operably function as taughtusing the methods taught herein.

FIGS. 6A-6D show a proximal handle 609 and a distal handle 611 in apistol-grip orientation with the body 612 of the anoscope 650. Theproximal handle 609 is operable attached to the shutter 660 and thedistal handle 611. The distal handle 611 is operably attached to thebody 612. FIGS. 6A and 6B show a side and bottom view of the anoscope650 in a shutter-open position, and FIGS. 6C and 6D show a side andbottom view of the anoscope 650 in a shutter-closed position. FIGS. 6Band 6D show a portion of a retraction coil spring 688 that provides atension for retracting the shutter from the shutter-closed position tothe shutter-open position. And, FIGS. 6A and 6C show a latch-typelocking mechanism 689 for securing the shutter 660 in the shutter-closedposition. The shutter-closed position includes the slightly retractedposition of the shutter 660 as described herein in which a tissue isgently secured under a controlled, or limited, pressure for theocclusion of the vascular supply to the hemorrhoid. This is because theshutter 660 can be operably and slidably attached to the proximalhandle, for example, using a compression coil spring 687 (not shown)that limits the amount of pressure that can be applied by the pinchingsurfaces 656,661 to the fold of tissue.

FIGS. 7A and 7B illustrate an exploded view of therapeutic anoscopeswith and without components for delivering energy for occlusion of avascular supply to a hemorrhoid, according to some embodiments. Theanoscope 750 has a proximal handle 709 and a distal handle 711. Theproximal handle 709 is operable attached to the shutter 760. The distalhandle 711 and the body 712 are formed in a two-piece assemblyconfiguration, whereas the shutter 760 and the proximal handle 709 areeach single-piece units. The distal handle is operably attached to thebody in a pistol-grip configuration. FIGS. 7A and 7B show a compressioncoil spring 787 that limits the amount of pressure that can be appliedby the pinching surfaces 756,761 to the fold of tissue. There is also aretraction coil spring 788 (not shown) that provides a tension forretracting the shutter from the shutter-closed position to theshutter-open position. A latch-type locking mechanism 789 is alsoprovided for securing the shutter 760 in the shutter-closed position.The shutter-closed position includes the slightly retracted position ofthe shutter 760 as described herein in which a tissue is gently securedunder a controlled, or limited, pressure for the occlusion of thevascular supply to the hemorrhoid. This is because the shutter 760 canbe operably and slidably attached to the proximal handle, for example,using the compression coil spring 787 that limits the amount of pressurethat can be applied by the pinching surfaces 756,761 to the fold oftissue. FIG. 7B also shows electrical components 733 a,733 b,733 c,733d,733 e for delivering an energy to the pinching surfaces 756,761 foroccluding the vascular supply the hemorrhoid. Input 733 a provides acircuit for the flow of an energy through a window contact 733 b and ashutter contact 733 c as they are brought a sufficiently close proximityfor the transfer of the energy, such as during the gently securing ofthe fold of rectal tissue to occlude the vascular supply to thehemorrhoid. Connectors 733 d,733 e provide a connection between theinput 733 a and the shutter contact 733 c. As the contacts 733 b,733 care brought in close proximity during the gently securing of the tissue,the circuit closes, energy passes, and the occlusion of the vascularsupply occurs.

The pinching surfaces can have any configuration that one of skillbelieves will effectively pinch and gently secure a fold of rectaltissue as described herein. In some embodiments, the pinching surfacescan be arcuate in shape to facilitate the grasping or pinching of thetissue as it enters the window of the body of the anoscope. The arcuateshape can reflect the convex shape of the body in regions adjacent tothe window. Likewise, the shutter can also have an arcuate shape. Thepinching surfaces can also have a contact surface that is smooth orrough, with raised protrusions, dimples, ridges, and the like. In someembodiments, the pinching surfaces can have a series of vertical smallelectrodes having gaps in-between the electrodes. An example of such aconfiguration could include serrations, channels, or grooves, of any ofa variety of configurations. Such an arrangement can provide anapplication of energy in spots or islands, rather than uniformly acrossthe pinching surface, to allow delivery of more energy to a thickertissue in a focused manner, allowing tissue to remain untreated betweenthe gaps to help ensure a minimal amount of damage to the rectal tissueand, at least, avoid necrosis in the tissue fold.

Energy can be applied to the fold selectively, and in a targeted manner,in some embodiments. That is, in some embodiments, energy is not appliedall around the tissue tissue fold but, rather, is selectively applied ina targeted manner to occlude the vascular supply to the hemorrhoid whilepursuing the least damage to the surrounding, collateral tissue. In someembodiments, the result of the application of energy includes coagulatedvessels, sclerosis, and no substantial necrosis in the tissue fold. Insome embodiments, the tissue fold can be between about 1 mm to about 6mm in thickness when compressed. And, in some embodiments, the tissuefold can be between about 2 mm to about 4 mm in thickness whencompressed. In some embodiments, the thickness of the tissue fold can beabout 0.5 mm, 1.0 mm, 2.5 mm, 3.5 mm, 4.5 mm, 5.5 mm, 6.5 mm, 7.5 mm, orany 0.5 mm increment therein. As described herein, the effectivetreatment time for an application of energy can vary. It should beappreciated that heterogeneity of tissue can naturally be a part of atissue fold, and the thickness and heterogeneity of tissue can affectthe treatment time that is found to be effective. In some embodiments,the temperature of an applied heat ranges from about 50° C. to about 65°C., and the treatment time can range, for example, from about 8 secondsto about 25 seconds.

In some embodiments, a heterogeneous tissue fold can be exposed to amoderate temperature, between about 50° C. and about 65° C., and thetissue is simultaneously compressed. The pressure, temperature, and timeof application of energy is balanced to target the endothelium of thevessels and some submuscosa, and the collateral tissue is spared. Theentire fold becomes moderately ischemic and form a beneficial scar.

FIGS. 8A-8F illustrate aspects of therapeutic anoscopes with and withoutcomponents for delivering energy for occlusion of a vascular supply to ahemorrhoid, according to some embodiments. FIGS. 8A and 8C show ananoscope 850 configured for delivering energy without any additionalsystem components, save for an energy source (not shown), whereas FIGS.8B and 8D show an anoscope 850 that is not configured to deliver anenergy in the absence of a separate system component, meaning that theanoscope 850 in FIGS. 8B and 8D could be used with the delivery of anenergy, but the energy would derive from a separate component throughthe body 812. As can be seen in FIGS. 8A and B, the body 812 can betransparent or translucent to assist the user of the anoscope 850. Insome embodiments, the anoscope body 812 can be configured for providinga length 813 sufficient to position the pinching surfaces 856,861 abovethe dentate line in the subject. The length 813 can include twocomponent distances, such as a window distance 813 a and a viewing portdistance 813 b. Window distance 813 a is the distance from the distalend 812 b of the anoscope body 812 to the proximal side 855 a of thewindow 855. The viewing port distance 813 b is the distance from thedistal end 812 b of the anoscope body 812 to the proximal end 812 a ofthe anoscope body 812.

In some embodiments, the anoscope body 812 can be configured forproviding a volume 817 in the lumen 819 sufficient for receiving thefold of the rectal tissue for the occluding of the vascular supply tothe hemorrhoid. Volume can be considered proportional to diameter, inembodiments that use a round, or substantially round, cylindricallyshaped body 812. The distal end 812 b of the body 812 can range indiameter, for example, from about 1.0 cm to about 3.0 cm, from about 1.5cm to about 2.5 cm, from about 1.6 cm to about 2.3 cm, from about 1.2 cmto about 2.7 cm, or any range therein. The region of the body 812 thatincludes the window 855 can range in diameter, for example, from about1.0 cm to about 4.0 cm, from about 1.5 cm to about 3.5 cm, from about1.8 cm to about 3.3 cm, from about 1.4 cm to about 2.0 cm, or any rangetherein. And, as taught herein, the region around the window 855 canhave a convex region, or bulging portion, that can help facilitate entryof a rectal tissue into the window 855. The proximal end 812 a of thebody 812 can range in diameter, as well, and one of skill will be ableto select a diameter that provides a visualization 885 of the fold for aparticular device, as well as an adequate entry of another component asneeded during a hemorrhoid treatment procedure. The anoscope 850 can beconfigured to (i) provide a visualization 895 of the rectal tissuewithout an image transmission through optic fibers and (ii) facilitatean ischemic regression of the hemorrhoid through the occluding to treatthe hemorrhoid in a manner that provides substantially less postprocedural pain to the subject than a hemorrhoid treatment procedurethat does not avoid the removal or the necrosis of the rectal tissue.

The window 855 of the anoscope 850 can have dimensions that facilitateentry of the rectal tissue into the window 855. In some embodiments, thewindow 855 can have a width 855 a ranging from about 0.5 cm to about 2.5cm, from about 0.75 cm to about 2.25 cm, from about 1.0 cm to about 2.0cm, from about 0.75 cm to about 1.75 cm, or any range therein. In someembodiments, the window 855 can have a length from about 0.5 cm to about3.5 cm, from about 0.75 cm to about 3.0 cm, from about 1.0 cm to about2.5 cm, from about 0.75 cm to about 2.75 cm, or any range therein.

In some embodiments, the shutter 860 can be configured for opening thewindow 855 to allow the rectal tissue to enter the window 855 during thetreatment of the hemorrhoid in the subject; creating the fold in therectal tissue orally to the hemorrhoid; and, gently securing the foldwith the limited pressure above the dentate line to avoid the removal orthe necrosis of the rectal tissue that creates the trauma to thesubject. And, as shown in FIGS. 8E and 8F, and as otherwise describedherein, the anoscope 850 can have a retraction coil spring 888 and acompression coil spring 887, the retraction coil spring provide atension for returning the shutter from a closed, or tissue securing,position to an open position, and the compression coil springcontrolling, or limiting, the pressure that can be applied to the rectaltissue by the pinching surfaces of the anoscope.

In some embodiments, the volume 817 is sufficient for a suturing toselectively ligate the vascular supply during the occluding whileotherwise avoiding the removal or the necrosis of the rectal tissuefold. And, in some embodiments, the volume 817 is sufficient for anapplication of heat at a temperature of about 50° C. to about 65° C. foran effective time to selectively coagulate the vascular supply duringthe occluding while avoiding a necrosis of the rectal tissue fold.Moreover, in some embodiments, the volume 817 is sufficient for anapplication of an RF energy to selectively coagulate the vascular supplyduring the occluding while avoiding a necrosis of the rectal tissuefold. In some embodiments, the RF energy or heat can be applied suchthat the temperature is ramped at a desired rate and heated for aneffective amount of time to occlude the vascular supply to thehemorrhoid while otherwise avoiding damage to tissue surrounding thevascular supply. The anoscope 850 also provides a visualization 885, aproximal handle 809, a distal handle 811, a shutter 860, and a lockingmechanism 889.

In some embodiments, the anoscope body has a central axis, and thelimited pressure is applied in the same, or substantially same, plane asa plane formed by the rectal tissue before the pinching, and at an angleranging from about 0 degrees to about 90 degrees from the central axis.And, in some embodiments, the anoscope body is translucent ortransparent.

In some embodiments, a therapeutic anoscope is presented for treating aprolapsed hemorrhoid in a subject in a manner that creates substantiallyless post-procedural pain. The anoscope can have a cylindrical, orsubstantially cylindrical, anoscope body having a lumen, a proximalopening, a distal end configured for a first point of entry into an anusof a subject. The body can also include a side window having a shutterand pinching surfaces to form a fold in a rectal tissue orally to aprolapsed hemorrhoid and gently secure the fold with a limited pressureabove a dentate line in a subject. The anoscope body can be configuredfor providing a length sufficient to position the pinching surfacesabove the dentate line in the subject; and, providing a volume in thelumen sufficient for receiving the fold of the rectal tissue for anoccluding of a vascular supply to the hemorrhoid. The shutter can beconfigured for opening the window to allow the rectal tissue to enterthe window during a treatment of a hemorrhoid in the subject; creatingthe fold in the rectal tissue orally to the prolapsed hemorrhoid; and,gently securing the fold with a limited pressure ranging from about 50kPa to about 1000 kPa above the dentate line to avoid a removal or anecrosis of the rectal tissue that creates a trauma to the subject. Itshould be appreciated that, in some embodiments, the rectal tissue canincorporate at least a portion of a hemorrhoid in a rectal tissue foldwhere, in some embodiments, the entire hemorrhoid may be incorporated.And, the anoscope can function to (i) directly visualize the rectaltissue without an endoscope having optic fibers and (ii) facilitate anischemic regression of the prolapsed hemorrhoid through the occluding.The anoscopes taught herein can be used to treat the hemorrhoid in amanner that provides substantially less post procedural pain to thesubject than a procedure that does not avoid the removal or the necrosisof the rectal tissue that creates trauma to the subject, facilitatingthe ischemic regression that results in a loss of bulk and weight in theprolapsed hemorrhoid.

It should be appreciated that the pinching surfaces that gently securethe tissue can have any configuration known to one of skill toaccomplish the act of gently securing the fold for the occluding of thevascular supply to the hemorrhoid. The configuration should provide asecuring surface and pressure that is gentle enough to avoid trauma tothe patient in a manner consistent with the teachings herein. In someembodiments, the pinching surfaces can have an arcuate shape tofacilitate a recruiting of the rectal tissue into the lumen of the bodyof the anoscope. And, in some embodiments, the pinching surfaces have aplurality of discrete regions on the pinching surfaces corresponding toa plurality of discrete areas on the fold to selectively coagulate thevascular supply during the occluding while preserving the remainder ofthe fold to avoid the removal or the necrosis of the rectal tissue fold.

A system for treating a hemorrhoid in a subject in a manner that createssubstantially less post-procedural pain is also provided herein. In someembodiments, the system comprises a therapeutic anoscope; and, anocclusion device operable for a targeted application of heat, energy, orligation to the vascular supply to the hemorrhoid, the targetedapplication otherwise avoiding damage to the rectal tissue. In someembodiments, the occlusion device applies RF energy to the vascularsupply to the hemorrhoid. In some embodiments, the occlusion devicefacilitates an application of a suture to the vascular supply to thehemorrhoid. And, in some embodiments, the occlusion device applies heatto the vascular supply to the hemorrhoid at a temperature ranging fromabout 50° C. to about 65° Cfor an effective time to selectivelycoagulate the vascular supply during the occluding while avoiding anecrosis of the rectal tissue fold.

Without intending to be limited to any theory or mechanism of action,the following examples are provided to further illustrate the teachingspresented herein. It should be appreciated that there are severalvariations contemplated within the skill in the art, and that theexamples are not intended to be construed as providing limitations tothe claims.

EXAMPLE 1 Comparison with Current Methods

This example compares current methods to the therapeutic anoscopemethods taught herein, described as “gentle systems”. The parameterscompared are invasiveness, pain, cost, and effectiveness. The methodsused as a comparison to the teachings provided herein are theenergy-based methods and rubber band methods currently used in thetreatment of hemorrhoids. Table 1 describes the comparison.

TABLE 1 The ratings from low to high are rated by the number of “+”symbols in a category, where the fewer number of symbols indicate “low”and the higher number of symbols “high.” As can be seen, the gentlesystems taught herein clearly outperform the state-of-the-art systems inmost every category, as well as when averaged across all categories.State-of-the-art The gentle- Doppler- systems Energy- Rubber suture-taught based banding Staples based herein Invasiveness + +/++ ++++ ++ +Pain +/+++ +/++ +++ ++/+++ + Cost +++ + ++++ ++++ + Effectiveness + +++++/++++ +++/++++ +++ Procedure +/++ +/++ ++++ ++++ + Time

EXAMPLE 2 Hemorrhoidal Superior Vessels Ligation Using Bipolar RF Eneravand Gentle Securing for Treatment of Internal Hemorrhoids

This example was a study of the effectiveness of an embodiment that usesa bipolar RF energy application, as described herein. Twenty-twopatients having stages internal hemorrhoids at stages I-IIIA weretreated. Table 2 describes the stages.

TABLE 2 Anal bleeding Definition Prolapse Definition Stage DefinitionMild Small amount Mild Reduces I Bleeding only, no of blood onspontaneously hemorrhoidal prolapse paper Moderate Moderate or ModerateRequires occasional II Mild hemorrhoidal more early or periodic manualprolapsed with significant reduction (usually spontaneous reductionamount of during constipation) blood on paper Severe Blood is ModerateRequires routine IIa Mild hemorrhoidal dripping in advanced manualreduction prolapsed, requiring toilet bowl occasional or periodic manualreduction (usually during constipation), may or may not have bleedingSevere Cannot be effectively IIIb Moderate hemorrhoidal reducedprolapsed, requiring routine manual reduction, may or may not havebleeding. IV Severe prolapsed, may or may not have bleeding

Table 3 describes the distribution of conditions among the twenty-twopatients.

TABLE 3 Patients # Patients # Patients # Bleeding (% total) Prolapse (%total) Stage (% total) Mild  4(18.2) Mild 10(45.5) I  6(27.3) Moderate12(54.5) Moderate  6(27.3) II 10(45.5) early Severe  6(27.3) IIIa 6(27.3) IIIb  0(0%) IV  0(0%) Total 22(100%0 16(72.3) 22(100)

The therapeutic anoscope provided RF energy across the rectal tissueunder a gentle compression, as described herein, to occlude the vascularsupply to the hemorrhoid in order to avoid unnecessary damage to thesurrounding tissues. The anoscope has a temperature sensor and isinserted intra-anally and the horizontal tissue fold just proximal tothe internal hemorrhoid is clamped. The RF energy then is delivered tothe clamped tissue until the tissue temperature reaches 55-60C. The timeof RF application ranged from 7 seconds to 29.6 seconds.

All internal hemorrhoids in left lateral, right anterior, and rightposterior positions were treated during one procedure. The twenty twopatients (100%) were followed at 4 weeks after the procedure. Sixteenpatients (73%) were available at an average 13.1 months follow-up[range: 12.7-17.1 months].

At 4 weeks follow-up, 3 patients reported 1 episode of mild analbleeding (13.6% vs. 100% pre-operatively or 86.7% improvement in thegroup), 1 patient reported mild prolapse (4.5% vs. 72.3% pre-operativelyor 67.8% improvement in the group). Among 3 patients who reported mildbleeding at 4 weeks follow-up, 1 patient pre-operatively had moderatebleeding and moderate prolapse, 1 patient pre-operatively had moderatebleeding and no prolapse, and 1 patient pre-operatively had severebleeding and mild prolapse. At an average 16.7 months follow-up, twopatients who had mild anal bleeding at 4 weeks follow-up reported noanal bleeding, and one patient was not available for a long-termfollow-up. The patient, who reported a mild prolapse and no bleeding at4 weeks follow-up, pre-operatively had severe bleeding and mildprolapse. This patient reported a resolution of the prolapse at 13.3months follow-up. The information on the symptomatic patients at 4 weeksfollow-up is summarized in Table 4.

At an average 13.1 months follow-up, 1 patient reported episodic mildanal bleeding (4.5% vs. 100% in the group or 95.5% improvement), whichpre-operatively reported severe bleeding and mild prolapse. None of thepatients reported prolapse at an average 13.1 months follow-up. Allpatients reported “significant improvement” in their hemorrhoidalsymptoms at an average follow-up of 13.1 months. The information on thesymptomatic patient at 13.3 months follow-up is summarized in Table 5.

TABLE 4 Symptoms at an Symptoms at Pre-operative average 13.1 monthsPatient 4 weeks symptoms follow-up 1 Mild anal Moderate bleeding and Nobleeding and no bleeding moderate early prolapsed prolapsed 2 Mild analModerate bleeding, no No bleeding and no bleeding prolapsed prolapsse 33 Mild anal Severe bleeding, mild No bleeding and no bleeding prolapsedprolapsed 4 Mild Mild prolapsed and No bleeding and no prolapsed severebleeding prolapse

TABLE 5 Symptoms at 13.3 Pre-operative Symptoms at 4 Patient monthsfollow-up symptoms weeks follow-up 1 Mild bleeding Severe bleeding, mildNo bleeding, no and mild anal prolapsed, severe prolapsed, anal painpain, persistent anal pain secondary secondary to anal fissure to analfissure persistent anal fissure

The methods taught herein, as used with the bipolar RF energy forocclusion of the superior hemorrhoidal blood supply for the treatment ofthe early symptomatic internal hemorrhoids (stages I-Ill early) showedsignificant improvement in pre-operative bleeding and prolapse. Whencompared to the pre-operative symptoms, at an average 13.1 monthsfollow-up, the mild-to-severe anal bleeding resolved in 95.5% (improvedin 100%) and mild-to-early moderate hemorrhoidal prolapse resolved in100% of the studied patients. Of 22 initially treated patients, 16patients (73%) were available for an average 13.1 months follow-up.

EXAMPLE 3 Hemorrhoidal Superior Vessels Ligation Using Gentle Securingof a Rectal Tissue Fold And Suturing For Treatment Of InternalHemorrhoids

This example illustrates a suture technique. The rectal tissue is firstidentified and gently secured using a therapeutic anoscope as describedherein. The tissue fold is the gently sutured to occlude the vascularsupply to the hemorrhoid.

The suture technique includes placing two sutures, led by needles thatare approximately 1.5 cm to 2.5 cm in length. The sutures aresubstantially parallel to each other and are passed through the lateralaspects of the tissue fold. Both needles are then pulled outside thebody of the anoscope along with the attached threads. The distal ends ofthe sutures, after the needles are cut off, are tied to each other usingconventional surgical knots to form the first set of knots. By pullingon the proximal ends of the threads, the first surgical set of knots isdelivered into the body of the anoscope and then pressed against theposterior surface of the tissue fold. The second set of surgical knotsis then tied between the proximal ends of two threads and, using asurgeon's finger or an instrument, is delivered into the body of theanoscope and then pushed against the anterior surface of the tissuefold.

The locking mechanism of the anoscope is then released, the gentlysecured tissue is released, and the anoscope is removed from the rectum.The tissue fold stays suture-fixed after the anoscope is removed. Thesuture assumes an oval configuration with the two sets of knots,constructs the superior hemorrhoidal blood supply, as well as constrictsand fixes the redundant tissue in a gentle manner to avoid anyunnecessary tissue damage to the patient.

1-12. (canceled)
 13. A therapeutic anoscope for treating a hemorrhoid ina subject while avoiding trauma associated with removing a rectaltissue, the anoscope comprising: a cylindrical, or substantiallycylindrical, anoscope body having a lumen, a proximal opening, a distalend configured for a first point of entry into an anus of a subject, anda side window having a shutter and pinching surfaces to form a fold in arectal tissue orally to a hemorrhoid and gently secure the fold with alimited pressure above a dentate line in a; wherein, the anoscope bodyis configured for providing a length sufficient to position the pinchingsurfaces above the dentate line in the subject; and, providing a volumein the lumen sufficient for receiving the fold of the rectal tissue foran occluding of a vascular supply to the hemorrhoid; the shutter isconfigured for: opening the window to allow the rectal tissue to enterthe window during a treatment of a hemorrhoid in the subject; creatingthe fold in the rectal tissue orally to the hemorrhoid; and, gentlysecuring the fold with the limited pressure above the dentate line toavoid a removal or a necrosis of the rectal tissue that creates a traumato the subject; and, the anoscope functions to (i) provide avisualization of the rectal tissue without an image transmission throughoptic fibers and (ii) facilitate an ischemic regression of thehemorrhoid through the occluding subsequent to gently securing the foldto treat the hemorrhoid in a manner that provides substantially lesspost procedural pain to the subject than a hemorrhoid treatmentprocedure that does not avoid the removal or the necrosis of the rectaltissue fold.
 14. The anoscope of claim 13, wherein the anoscope includesa means for securing the fold with a controlled pressure to provide aconstant tissue fold configuration.
 15. (canceled)
 16. The anoscope ofclaim 13, wherein the limited pressure ranges from about 50 kPa to about1000 kPa.
 17. The anoscope of claim 13, wherein the volume is sufficientfor a suturing to selectively ligate the vascular supply during theoccluding while otherwise avoiding the removal or the necrosis of therectal tissue fold.
 18. The anoscope of claim 13, wherein the volume issufficient for an application of heat at a temperature of about 50° C.to about 65° C. for an effective time to selectively coagulate thevascular supply during the occluding while avoiding a necrosis of therectal tissue fold.
 19. The anoscope of claim 13, wherein the volume issufficient for an application of an RF energy to selectively coagulatethe vascular supply during the occluding while avoiding a necrosis ofthe rectal tissue fold.
 20. The anoscope of claim 13, wherein the bodyhas a central axis, and the limited pressure is applied in the same, orsubstantially same, plane as a plane formed by the rectal tissue beforethe pinching, and at an angle ranging from about 0 degrees to about 90degrees from the central axis.
 21. The anoscope of claim 13, wherein thebody is translucent or transparent. 22-28. (canceled)
 29. The anoscopeof claim 13, wherein the pinching surfaces have an arcuate shape tofacilitate recruiting the rectal tissue into the lumen of the body ofthe anoscope.
 30. (canceled)
 31. A system for treating a hemorrhoid in asubject in a manner that creates substantially less post-proceduralpain, the system comprising: the therapeutic anoscope of claim 13; andan occlusion device operable for a targeted application of heat, energy,or ligation to the vascular supply to the hemorrhoid, the targetedapplication otherwise minimizing damage to the rectal tissue. 32-34.(canceled)
 35. The anoscope of claim 14, wherein the fold is gentlysecured with a controlled pressure to provide a constant tissue pressureby a spring mechanism.
 36. The anoscope of claim 13, wherein the fold isgenerally secured with a controlled pressure to provide a constanttissue pressure by providing the shutter with a material having amodulus of elasticity that prevents a user from applying a pressuregreater than the pressure that creates a strain of the material.
 37. Theanoscope of claim 13, wherein the fold is generally secured with acontrolled pressure to provide a constant tissue pressure by providingthe shutter with a material having a hardness that prevents a user fromapplying a pressure that creates a compression of the material.
 38. Atherapeutic anoscope for treating a hemorrhoid in a subject whileavoiding trauma associated with removing a rectal tissue, the anoscopecomprising: an anoscope body having a lumen, a distal end configured fora first point of entry into an anus of a subject, a side window, amovable shutter and pinching surfaces to pinch rectal tissue orally to ahemorrhoid and gently secure the tissue with a limited pressure above adentate line in a subject by limiting an amount of pressure pinchingsurfaces can apply to the rectal tissue, the shutter movable from afirst position to a second position to reduce a size of the window andapply the limited pressure, the shutter gently securing the tissue toavoid a removal or a necrosis of the rectal tissue that creates a traumato the subject, the anoscope including an occluding structure to occludea vascular supply by application of energy subsequent to the pinching ofthe rectal tissue by movement of the shutter to thereby occlude avascular supply to the hemorrhoid to facilitate an ischemic regressionof the hemorrhoid through the occluding to reduce the weight of thehemorrhoid and treat the hemorrhoid in a manner that providessubstantially less post procedural pain to the subject than a hemorrhoidtreatment procedure that does not avoid the removal or the necrosis ofthe rectal tissue.
 39. The anoscope of claim 38, wherein the shutterprovides a controlled pressure to provide a constant tissue pressure onthe rectal tissue received in the window, wherein the controlledpressure includes spring regulated pressure.
 40. The anoscope of claim38, wherein energy is applied from a region of the pinching surfaces tothe rectal tissue.
 41. The anoscope of claim 38, wherein the pinchingsurfaces have an arcuate shape and include a first pinching surface onthe shutter and a second pinching surface on the window.
 42. Theanoscope of claim 38, wherein the shutter slides in a directionsubstantially parallel to the longitudinal axis of the anoscope body.43. The anoscope of claim 38, further comprising a locking mechanism tosecure the shutter in the second position.
 44. The anoscope of claim 38,further comprising a retraction spring to provide a tension to retractthe shutter from the second position to the first position.
 45. Theanoscope of claim 44, further comprising a compression spring to limitthe amount of pressure than can be applied by the pinching surfaces. 46.The anoscope of claim 38, wherein the anoscope includes temperaturesensor.
 47. The anoscope of claim 38, wherein the occluding structure isa separate structure insertable into the lumen of the anoscope.